Atrial rhythm abnormalities are associated with the development of blood clots in the atrial chamber, which can result in the formation of thrombus and emboli which may (among other things) cause brain stroke. The left atrial appendage (“LAA”) is particularly susceptible to clot formation. Several approaches were developed to reduce the risk of clot formation in the LAA, mainly consisting in physically separating or occluding the LAA from the left atrium. Said devices reduce the risk of blood clots in the LAA and/or obstruct or filter the flow of clots from the LAA into the atrium. One example of the separation devices are permanently-implanted occluders. Permanently-implanted occluders (e.g., Watchman®) are usually introduced transseptally up to the LAA by a delivery cathether and then the device is anchored at the desired location by fixation barbs or other methods.
An example of such an occlusion device is shown in FIG. 1, which illustrates how a Watchman occlusion device 100 is introduced through the right atrium 101 and transseptally catheterized, as shown at 103, to reach the LLA 102 (image taken from http://www.hkma.org/english/cme/clinicalcase/201003a_set.htm).
A second example of physical separation of LAA is described in U.S. Pat. No. 7,427,279, which discloses a closure catheter comprising deployable tissue anchors. The device is to be inserted up to the LAA. Once located properly, the anchors are deployed into the surrounding tissue and draw the tissue radially inwardly to close the LAA cavity.
A third example of physical separation of LAA are permanently implanted clip (e.g., The AtriClip™ LAA Exclusion System—http://www.atricure.com) which contains an LAA Clip for open occlusion of the heart's left atrial appendage. The Clip is pre-loaded on a disposable Clip applier. Said clips are located extraluminally, and require open-chest surgery.
Blood clot formation in the LAA is managed also by anticoagulant therapies, such as Warfarin (Coumadin). Said therapies cause significant complications in 1-2% of patients a year.
Although a variety of procedures has been suggested for overcoming the problem, all procedures known in the art are either long and complex, or present severe dangers resulting from perforation of the cardiac (left atrial and LAA) wall, or from the voluntary or involuntary removal of portions of the LAA, and many present both drawbacks. Therefore, so far the art has failed to provide a simple and safe method to perform the closure of the LAA, and no attempts have been made to evaginate it as a stage of a closure procedure.
It is an object of the invention to provide a method and apparatus for repositioning a body part.
It is another object of the invention to provide a device that permits to perform a medical procedure by which there is evagination and then constant fixation in the left atrium of the LAA, which can be safely performed without the danger of damaging the LAA tissue.
It is yet another object of the invention to provide a device suitable for carrying out a procedure at the end of which the repositioned LAA is covered by not-thrombogenic endocardium and cannot harbor blood clots.
Other objectives and advantages of the invention will become apparent as the description proceeds.